Gland Pharma IPO
(i) They one of the fastest-growing generic injectables-focused companies by revenue in the United States from 2014 to 2019 (Source: IQVIA Report). They are present in sterile injectables, oncology, and ophthalmics, and focus on complex injectables, NCE-1s, First-to-File products, and 505(b)(2) filings. Gland Pharma is typically a B2B company.
Generic injectables are bio-equivalent of their branded counterparts which are not protected by drug patents. They are as safe and effective as the innovator drugs since they have similar active ingredients, dosage, strength, quality, form, etc.
(ii) They sell their products primarily under a business to business (“B2B”) model in over 60 countries as of March 31, 2020, including the United States, Europe, Canada, Australia, India, and the Rest of the world.
(iii) Gland Pharma was established in Hyderabad, India in 1978 and has expanded from liquid parenterals to cover other elements of the injectables value chain, including contract development, own development, dossier preparation, and filing, technology transfer, and manufacturing across a range of delivery systems.
(iv) They have a professional management team and one of the Promoters, Shanghai Fosun Pharma, is a global pharmaceutical major.
(v) Gland Pharma has seven manufacturing facilities in India, comprising four finished formulations facilities with a total of 22 production lines and three API facilities. As of March 31, 2020, they have manufacturing capacity for finished formulations of approximately 755 million units per annum.
(vi) As of March 31, 2020, Gland Pharma along with its partners had 265 ANDA filings in the United States, of which 204 were approved and 61 were pending approval. The 265 ANDA filings comprise 189 ANDA filings for sterile injectables, 50 for oncology and 26 for ophthalmics related products.
ANDA– An abbreviated new drug application (ANDA) contains data that is submitted to the FDA for the review and potential approval of a generic drug product.
Revenue Contributions Country-wise
|Rest of the world||5.10%||11.59%||8.80%|
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